AccessGUDID - DEVICE: Prometra Tunneler (00810335020150)

GUDID

Device Identifier (DI) Information

Brand Name: Prometra Tunneler
Version or Model: 11826
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Flowonix Medical, Inc.

Primary DI Number: 00810335020150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013518517 *Terms of Use

Device Description: The Tunneler is used for subcutaneous placement of the Intrathecal Catheter. It is a sterile, malleable stainless steel tunneler with a pointed tip to penetrate subcutaneous tissue and a threaded end for attachment to the Intrathecal Catheter.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46801	Subcutaneous tunneller, single-use	A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKK	Pump, Infusion, Implanted, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080012	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b556488-4fd4-4a77-b903-53e8de9a18c6
Public Version Date: February 05, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2014